Tokyo, July 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061672) titled 'Validation of Innovative Transcutaneous Assessment of fLuid status Using Intravenous fluid loading in healthy adults' on July 1.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Tohoku University
Condition:
Condition - N/A
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The purpose of this study is to evaluate the validity of a newly developed transcutaneous body fluid measurement method in healthy adults.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - A 1-L intravenous fluid loading test using normal saline and 5% glucose solution will be performed.
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1.Adults aged 18 years or older
2.Individuals with no history of being diagnosed with arrhythmia during health checkups or medical examinations
3.Individuals who are able to participate in the study conducted over two separate sessions
4.Individuals who have provided written informed consent for participation in the study
Key exclusion criteria - 1.History of cardiovascular disease
2.Presence of any disease that may affect the cardiovascular system
3.Current use of medications that may affect the cardiovascular system
4.History of vasovagal reactions during blood sampling
5.Inability to maintain a resting position during the study procedures
6.Individuals deemed unsuitable for participation in this study by the investigators
Target Size - 30
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 06 Month 30 Day
Anticipated trial start date - 2026 Year 07 Month 01 Day
Last follow-up date - 2027 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070568
Disclaimer: Curated by HT Syndication.
